Genetic CounselingNCT02586428
Noninvasive Prenatal Testing
An observational study of Genetic Counseling, run by St. Louis University at 1 site in United States.
Trial summary
Before and after a patient receives genetic counseling they will be offered the chance to complete the survey, by their counselor. Since each patient sees only one genetic counselor that counselor will be responsible for consenting and giving and collecting the finish surveys. No identifiers will be used. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Genetic Counseling
- What is being tested?
- what patients elect noninvasive prenatal testing (NIPT)
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients who have abnormal ultrasound findings, advance maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. These patients will be scheduled ahead of time with the genetic counseling.
Who may be able to join
- high risk pregnant women seen for genetic counseling
Who cannot join
- low risk
- not pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decision-Making in Patients Regarding Noninvasive Prenatal Testing
Before and after a patient receives genetic counseling they will be offered the chance to complete the survey, by their counselor. Since each patient sees only one genetic counselor that counselor will be responsible for consenting and giving and collecting the finish surveys. No identifiers will be used. The investigators will emphasize that their answers will remain anonymous throughout the entire process, and that their participation is strictly voluntary. The patient will be provided with a survey and asked to complete this before their genetic counseling session and after.The survey will be returned to the genetic counselor and placed in a locked drawer. Information will also be collected from the medical record including age, pregnancy history and the reason for the visit.
Read the detailed description
Patients who have abnormal ultrasound findings,advanced maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. Prior to receiving genetic counseling, the genetic counselor or her designee will approach the patient asking if she would be willing to participate in a survey that helps us better determine how well patients understand their testing options for the above issues.
The survey consists of two parts. The first part will be taken prior to genetic counseling to see what the patient's baseline understanding of their options are (this is study related.) If the patient agrees to participate in the study, she will then receive the first part of the survey. After completion of the first part of the survey, the patient will then receive genetic counseling (this is standard of care.). Information will also be collected from the medical record including age, pregnancy history and the reason for the visit. After receiving genetic counseling for their specific indication, patients will decide if they want noninvasive prenatal testing, amniocentesis, testing depending what their ultrasound shows, or no testing. After this the patient will be given the second part of the survey to complete (this is study related). Regardless of which testing is elected, (if any), participants are administered the same survey. After completing the survey, the patient will return the form to the genetic counselor or her designee. The recruitment period is expected to last approximately one year. After recruitment is completed, data analysis will take place. Interim data analysis make take place as well.
Patients will not be contacted for research purposes after the survey has been completed.
After patients complete this survey, they will require no further information. They are not being administered a treatment or receiving a direct benefit from participation; the study is designed only to obtain information about patient's decisions, knowledge, and attitudes regarding their testing options.
- Conditions
- Genetic Counseling
- Being tested
- what patients elect noninvasive prenatal testing (NIPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
what patients elect noninvasive prenatal testing (NIPT)Other
what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling.
What is being measured
The primary outcome is the main question the study is designed to answer.
will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling
percentages of patient's choices
Measured: over the next 6 months
Secondary outcomes (2)
will measure patients' reasons for electing or not electing testing
Reasons for not electing to have testing
Measured: over the next 6 months
Measure if patients' understand the different testing options.
Are they able to give explanation of testing
Measured: over next 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: difficult to enroll, Pi decision to closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fruhman@slu.edu, St. Louis University
- Investigators
- Gary Fruhman, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586428
- Sponsor's protocol ID
- 25878
- Status last verified
- Oct 2016
- First submitted
- 8 Sep 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-Making in Patients Regarding Noninvasive Prenatal Testing
- ClinicalTrials.gov ID
- NCT02586428
- Acronym / sponsor ID
- 25878
- Conditions
- Genetic Counseling
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficult to enroll, Pi decision to closed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Before and after a patient receives genetic counseling they will be offered the chance to complete the survey, by their counselor. Since each patient sees only one genetic counselor that counselor will be responsible for consenting and giving and collecting the finish surveys. No identifiers will be used. The investigators will emphasize that their answers will remain anonymous throughout the entire process, and that their participation is strictly voluntary. The patient will be provided with a survey and asked to complete this before their genetic counseling session and after.The survey will be returned to the genetic counselor and placed in a locked drawer. Information will also be collected from the medical record including age, pregnancy history and the reason for the visit.
Detailed description
Patients who have abnormal ultrasound findings,advanced maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. Prior to receiving genetic counseling, the genetic counselor or her designee will approach the patient asking if she would be willing to participate in a survey that helps us better determine how well patients understand their testing options for the above issues.
The survey consists of two parts. The first part will be taken prior to genetic counseling to see what the patient's baseline understanding of their options are (this is study related.) If the patient agrees to participate in the study, she will then receive the first part of the survey. After completion of the first part of the survey, the patient will then receive genetic counseling (this is standard of care.). Information will also be collected from the medical record including age, pregnancy history and the reason for the visit. After receiving genetic counseling for their specific indication, patients will decide if they want noninvasive prenatal testing, amniocentesis, testing depending what their ultrasound shows, or no testing. After this the patient will be given the second part of the survey to complete (this is study related). Regardless of which testing is elected, (if any), participants are administered the same survey. After completing the survey, the patient will return the form to the genetic counselor or her designee. The recruitment period is expected to last approximately one year. After recruitment is completed, data analysis will take place. Interim data analysis make take place as well.
Patients will not be contacted for research purposes after the survey has been completed.
After patients complete this survey, they will require no further information. They are not being administered a treatment or receiving a direct benefit from participation; the study is designed only to obtain information about patient's decisions, knowledge, and attitudes regarding their testing options.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who have abnormal ultrasound findings, advance maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. These patients will be scheduled ahead of time with the genetic counseling.
Key inclusion criteria (1 listed)
- high risk pregnant women seen for genetic counseling
Key exclusion criteria (2 listed)
- low risk
- not pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| what patients elect noninvasive prenatal testing (NIPT)what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling. | Other | – |
Primary outcome
will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling
Time frame: over the next 6 months
percentages of patient's choices
2 secondary outcomes
will measure patients' reasons for electing or not electing testing
Time frame: over the next 6 months
Measure if patients' understand the different testing options.
Time frame: over next 6 months
Results and safety
The study was stopped early (reason given: difficult to enroll, Pi decision to closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Fruhman, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Counseling, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficult to enroll, Pi decision to closed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling (time frame: over the next 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.